FJG · Class II · 21 CFR 876.5820

FDA Product Code FJG: Dialyzer, Parallel Flow

Leading manufacturers include Gambro, Inc., Cobe Laboratories, Inc. and Hospal Medical Corp..

36
Total
36
Cleared
91d
Avg days
1977
Since

FDA 510(k) Cleared Dialyzer, Parallel Flow Devices (Product Code FJG)

36 devices
1–24 of 36
Cleared Sep 21, 1992
DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9
K920693
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 220d
Cleared Aug 01, 1990
TENCKHOFF PERITONEAL DIALYSIS KIT
K902203
Akcess Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Sep 29, 1986
GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N
K862840
Gambro, Inc.
Gastroenterology & Urology · 62d
Cleared Jan 08, 1986
GAMBRO LUNDIA PRO 3 & 5 DIALYZER
K853406
Gambro, Inc.
Gastroenterology & Urology · 149d
Cleared Mar 31, 1982
COBE PPD 1.3L, #18-520-009
K820694
Cobe Laboratories, Inc.
Gastroenterology & Urology · 19d
Cleared Aug 31, 1981
COBE PPD 1.9
K812336
Cobe Laboratories, Inc.
Gastroenterology & Urology · 13d
Cleared Jun 12, 1981
EXP 200 PARALLEL PLATE DIALYZER
K811439
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 21d
Cleared Jun 12, 1981
EXP 600 PARALLEL PLATE DIALYZER
K811440
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 21d
Cleared Jun 09, 1981
COBE PPD .8
K810066
Cobe Laboratories, Inc.
Gastroenterology & Urology · 147d
Cleared Jan 29, 1981
EXTRACORPOREAL'S EXP 400 PARALLEL PLATE
K802364
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 122d
Cleared Dec 22, 1980
GAMBRO LUNDIA PLATE DISP. DIALYZER
K802389
Gambro, Inc.
Gastroenterology & Urology · 84d
Cleared Apr 10, 1980
LUNDIA PLATE DISP.
K800424
Gambro, Inc.
Gastroenterology & Urology · 44d
Cleared Feb 06, 1980
GAMBRO LUNDIA PLATE DIALYZER
K792611
Gambro, Inc.
Gastroenterology & Urology · 50d
Cleared Nov 13, 1979
EXTRACORPOREAL'S MODEL EX-85 DIALYZER
K791961
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 43d
Cleared Aug 07, 1979
HEMODIALYZERS RP-510 AND RP-514
K791448
Hospal Medical Corp.
Gastroenterology & Urology · 1d
Cleared May 02, 1979
HD CAPILLARY FILM DIALYZER, MODEL 1001
K790533
Travenol Laboratories, S.A.
Gastroenterology & Urology · 48d
Cleared Mar 06, 1979
DIALYZER, MODEL F.M.D 150
K790001
Hospal Medical Corp.
Gastroenterology & Urology · 63d
Cleared Feb 21, 1979
DIALYZER, MAGNIFLO 100 PARALLEL PLATE
K781966
Erika, Inc.
Gastroenterology & Urology · 89d
Cleared Jul 17, 1978
LUNDIA PLATE DISPOSABLE DIALYZER
K780700
Gambro, Inc.
Gastroenterology & Urology · 82d
Cleared May 19, 1978
RP-510/RP-514 PARALLEL PLATE DIALYZERS
K780427
Hospal Medical Corp.
Gastroenterology & Urology · 63d
Cleared Jan 26, 1978
DIALYZER STANDARD, CODE 5DM1780
K772318
Travenol Laboratories, S.A.
Gastroenterology & Urology · 38d
Cleared Sep 15, 1977
PARALLEL PLATE DIALYZERS
K771354
Hospal Medical Corp.
Gastroenterology & Urology · 55d
Cleared Jun 14, 1977
DIALYZER, ULTRADIFFUSER, DISPOSABLE
K770858
Gambro, Inc.
Gastroenterology & Urology · 36d
Cleared Apr 15, 1977
PARALLEL PLATE DIALYZER
K770578
Cobe Laboratories, Inc.
Gastroenterology & Urology · 18d

About Product Code FJG - Regulatory Context